Laboratory Standards
The complete ASF accreditation standard for medical laboratories — standalone, hospital, or clinic laboratories alike. Every criterion is published in full — statement, classification, and the verification questions used by Monitors and supervisors. Free. No account required.
This is ASF’s own accreditation standard for laboratory governance, safety, and patient-facing practice — distinct from ISO 15189 Ready, which is a separate, downloadable documentation pack that prepares a laboratory for ISO 15189 assessment by its national accreditation body. A laboratory can use either, both, or neither; this standard does not require ISO 15189 Ready, and ISO 15189 Ready does not require ASF accreditation.
How to read this page: Each standard groups related criteria. Each criterion has a classification — Non-Negotiable (all must be met; any single failure bars accreditation), Core (≥85% for accreditation, ≥70% for certification), or Standard (≥70% for accreditation). The verification questions show what a Monitor checks. To test your facility against these criteria, use the free self-assessment tool.
Non-Negotiable weight 3× — patient safety absolutes · Core weight 2× — essential quality practices · Standard weight 1× — good practice
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Full Guidance Edition (worked examples, implementation plans, Monitor verification — every criterion)
Contents
Standard 2 — Management Requirements (8 criteria)
Standard 3 — Personnel & Competence (5 criteria)
Standard 4 — Equipment, Reagents & Traceability (8 criteria)
Standard 5 — Facilities, Environment & Suppliers (6 criteria)
Standard 6 — Pre-Examination: Specimen Pathway (8 criteria)
Standard 7 — Examination: Process & Safety (8 criteria)
Standard 8 — Post-Examination: Reporting & Critical Values (8 criteria)
Standard 9 — Refugee & Migrant Health (8 criteria)
Discipline endorsements: once the core standard is met, a laboratory may add discipline-specific endorsements for the sections it actually runs — Clinical Biochemistry, Hematology, Coagulation, Immunology, and Urinalysis — the same endorsement model already used for Oncology and Addiction Treatment under the Ambulatory module. A laboratory activates only the disciplines it operates.
Governance & Document Control
Open full guidance for Standard 1 — worked examples, first steps, monitor methods →
Named Accountable Person
Non-Negotiable
A named individual — the Laboratory Director or an equivalent role — holds documented, final accountability for the quality management system. The name is current, not a vacant title inherited from a predecessor. Financial accountability is named separately, even where the same person holds both roles, and a brief, genuine statement of mission and values exists for the laboratory.
1. Is there a named, current Laboratory Director or equivalent, not a title left over from someone who has since left? — Verified against actual employment records, not an organizational chart that hasn’t been updated.
2. Does that person hold documented authority to stop unsafe testing or release of results? — Authority on paper only is not authority.
3. Can staff correctly name this person if asked directly? — If frontline staff don’t know who it is, the accountability is not functioning in practice.
4. Is financial accountability named separately from quality-system accountability, even if held by the same person? — A distinct, named responsibility, not assumed to be covered by the Director role alone.
5. Does a brief, genuine statement of mission and values exist, specific to this laboratory? — A real, specific statement, not an absence of one on the assumption a lab doesn’t need it.
Document Control: One Current Version
Non-Negotiable
Every controlled policy, procedure, and SOP exists in exactly one current, identifiable version at the bench. Superseded versions are removed from use, not merely marked obsolete while remaining accessible.
1. Pick any SOP at random at the bench — is it the current version, verifiable against the master document register? — Spot-checked, not taken on the laboratory’s word.
2. Are superseded versions physically or digitally removed from the work area, not just labeled “obsolete”? — A marked-obsolete copy still on the shelf gets used under pressure.
3. Is there a single master document register that lists every controlled document and its current version? — Not several partial lists kept by different section heads.
Document Approval Before Use
Non-Negotiable
No policy, procedure, or SOP is used at the bench before it has been formally reviewed and approved by the accountable person or their documented delegate.
1. Does every controlled document show a named approver and approval date before its effective date? — Not a document in active use with no visible sign-off.
2. Where approval is delegated, is the delegation itself documented and current? — An informal “they usually handle it” is not a documented delegation.
3. Can the laboratory produce the approval record for any document the Monitor selects at random? — On request, not after a delay to “find it.”
Risk Register, Reviewed on a Schedule
Core
A risk register identifies specific risks to result accuracy and patient safety across the specimen pathway, with a named owner and review date for each entry, reviewed on a fixed schedule rather than only after an incident.
1. Does the risk register name specific risks — not generic entries like “human error” with no detail? — Vague entries that could apply to any laboratory anywhere are not genuine risk identification.
2. Does each entry have a named owner responsible for it? — A risk with no owner does not get managed.
3. Is the register reviewed on a fixed schedule, verifiable by actual review dates, not only reactively after something goes wrong? — A register untouched for over a year despite a stated quarterly cycle fails this.
Retention Schedule Matches Legal Minimum
Core
A documented retention schedule states how long each record type — patient results, quality control data, equipment maintenance logs, competence records — is kept, and meets or exceeds the applicable national legal minimum.
1. Does a written retention schedule exist covering every major record type, not just patient results? — Equipment and competence records are frequently the gap.
2. Does each retention period meet or exceed the national legal minimum for that record type? — Checked against the actual current law, not an assumption carried over from years ago.
3. Can the laboratory retrieve a record from several years back within the stated retention period, not just recent ones? — A retention policy that exists on paper but fails in practice when records are actually needed.
Management Requirements
Open full guidance for Standard 2 — worked examples, first steps, monitor methods →
Internal Audit, On a Fixed Schedule
Non-Negotiable
The full quality management system is internally audited at least once per year against a documented audit schedule, covering every section of the laboratory over a defined cycle, not only the sections most convenient to review.
1. Does a documented audit schedule exist covering every laboratory section within a defined cycle? — Not just the sections an auditor finds easiest to reach.
2. Did the most recent audit actually happen on or near its scheduled date? — A schedule that is routinely missed is not functioning.
3. Are audit findings recorded in enough detail that someone outside the audit could understand what was actually checked? — A checklist with ticks and no detail is not a usable audit record.
Corrective Action Closes the Root Cause
Non-Negotiable
Every nonconformance with potential impact on patient results triggers a documented corrective action that identifies the root cause, not only the immediate symptom, and the action is verified as effective after implementation.
1. Pick a recent corrective action at random — does it name a root cause, or only restate the symptom? — “Staff error” is a symptom; what allowed the error to happen is the root cause.
2. Was the corrective action’s effectiveness checked after a defined interval, not just implemented and assumed to have worked? — A documented follow-up check, not an assumption.
3. Where the same type of nonconformance has recurred, was that recurrence itself investigated as a sign the original action failed? — A repeat failure without a fresh investigation suggests the corrective action process is not functioning.
Preventive Action, Not Only Reactive
Core
The laboratory identifies potential nonconformances before they occur — from trend data, near-misses, risk register entries, or external quality assessment patterns — and acts on them, not only responding after an actual failure.
1. Can the laboratory show at least one preventive action taken from trend data or a near-miss, not triggered by an actual failure? — If every action on file follows an actual incident, prevention is not genuinely functioning.
2. Is external quality assessment performance trended over time, not just checked pass/fail each round? — A single-round pass can mask a worsening trend across several rounds.
3. Is there a named person responsible for reviewing trends on a schedule? — Trend data nobody is assigned to review does not drive prevention.
Management Review, With Minutes and Actions
Core
Senior management formally reviews the quality management system at least annually, with documented minutes, inputs covering audits/complaints/nonconformances/external quality assessment, and tracked output actions with owners and dates.
1. Do management review minutes exist for the most recent cycle, with named attendees? — Not a verbal assurance that “we discussed it.”
2. Do the minutes cover the required inputs — audit results, complaints, nonconformances, external quality assessment performance? — A review that only covers budget is not a quality management review.
3. Are output actions from the previous review traceable to completion, with a named owner for each? — Actions agreed and never followed up are a common, specific failure.
Complaints Logged, Investigated, Closed
Core
Every complaint, from any source — patient, clinician, referring facility — is logged in a single register, investigated, and closed with a documented outcome communicated back to the complainant where contact information exists.
1. Does a single complaints register exist, or are complaints handled informally by whoever receives them? — Complaints handled verbally and never logged are effectively invisible to the quality system.
2. Is there a documented outcome for each logged complaint, not just a record that it was received? — Receipt without resolution is not complaint handling.
3. Where contact information exists, was the complainant actually informed of the outcome? — Closing a complaint internally without telling the person who raised it undermines trust.
Impartiality: No Commercial Pressure on Results
Non-Negotiable
No staff member’s remuneration, performance evaluation, or continued employment is tied, directly or indirectly, to the volume or outcome of specific test results. Laboratory personnel are protected from undue commercial or financial pressure that could influence technical judgment.
1. Is any part of technical staff compensation linked to test volume, result patterns, or referral relationships? — A volume-linked bonus for technical staff creates exactly the pressure this criterion prohibits.
2. Is there a documented policy explicitly protecting staff who report a quality concern from retaliation? — Protection that exists informally but isn’t written down fails under pressure.
3. Would a technician who identified a result requiring re-testing feel safe raising it, even if it delays turnaround? — Tested through confidential staff conversation, not management’s own assurance.
Conflict of Interest Declared and Reviewed
Core
Staff and management with influence over testing, purchasing, or reporting decisions declare financial or personal interests that could reasonably affect impartiality, and these declarations are reviewed on a fixed schedule, not only collected once at hiring.
1. Do current declarations exist for everyone in a position of influence, not just a one-time declaration from years ago? — Circumstances change; a declaration never refreshed becomes stale.
2. Is there a named person or body responsible for reviewing declarations and deciding what action, if any, is needed? — A declaration filed and never reviewed by anyone accomplishes nothing.
3. Where a genuine conflict was identified, is there a record of what mitigation was actually applied? — Identification without documented mitigation is incomplete.
External Service and Supply Evaluation
Core
Reference laboratories, equipment service providers, and critical reagent suppliers are formally evaluated before use and periodically thereafter, against documented criteria relevant to the service each provides.
1. Is there a documented evaluation on file for the laboratory’s current reference laboratory and key equipment service providers? — Not a relationship that began informally and was never formally assessed.
2. Are these evaluations repeated on a periodic schedule, not only at the start of the relationship? — A provider’s performance can decline over years without a fresh check.
3. Where a provider’s performance has been unsatisfactory, is there a record of how the laboratory responded? — Continuing with an underperforming provider with no documented response is a gap.
Personnel & Competence
Open full guidance for Standard 3 — worked examples, first steps, monitor methods →
Documented Qualification Before Independent Work
Non-Negotiable
No staff member performs a laboratory procedure unsupervised until their competence in that specific procedure has been formally assessed and documented, not merely inferred from a general qualification or job title.
1. Pick a staff member at random — does a documented competence record exist for every procedure they perform unsupervised? — A nursing or laboratory degree is not, by itself, documented competence in a specific procedure.
2. Was the competence assessment performed by someone else, not self-certified by the staff member? — Self-assessment of one’s own competence is not independent verification.
3. Is there a record of the actual date competence was confirmed, not just a start date of employment? — The two dates are often different and the distinction matters.
Competence Reassessed on a Schedule
Non-Negotiable
Staff competence is formally reassessed at defined intervals — not only at hiring — and immediately following any extended absence, procedural change, or identified performance concern.
1. Is there a fixed reassessment interval, and does the most recent reassessment date for staff fall within it? — A policy stating annual reassessment that hasn’t actually happened in two years fails this.
2. Following a staff member’s return from extended leave, was competence reconfirmed before they resumed unsupervised work? — Skills can lapse; resuming without reconfirmation is a real risk.
3. Where a performance concern was identified, was a targeted reassessment triggered specifically because of it? — Not just folded into the next routine cycle months later.
Orientation Before First Independent Shift
Core
Every new staff member completes a documented orientation covering the laboratory’s quality management system, safety procedures, and their specific role’s SOPs before working an unsupervised shift.
1. Does a signed orientation record exist for current staff, dated before their first unsupervised shift? — Dated after the fact does not satisfy this criterion.
2. Does orientation cover safety procedures specifically, not only administrative onboarding? — HR paperwork alone is not safety orientation.
3. Can a recently hired staff member describe what their orientation actually covered? — Verified by asking the person directly, not only checking the signed form.
Training Records Tied to Specific SOPs
Core
Training records name the specific SOP or procedure version a staff member was trained on, and are updated whenever that SOP is revised, so the laboratory can show at any time exactly which version of a procedure each staff member is currently qualified to perform.
1. Do training records name the specific SOP and version, not just a general subject area? — “Trained on specimen handling” is too vague; which SOP, which version?
2. When an SOP was last revised, were affected staff retrained and the record updated before the new version took effect? — A revised SOP with no corresponding retraining record is a gap.
3. Can the laboratory produce, for any current staff member, the exact list of SOP versions they are currently qualified on? — On request, without needing to reconstruct it from scattered files.
Adequate Staffing for Safe Operation
Core
Staffing levels at all operating hours are sufficient for safe specimen handling, timely result reporting, and compliance with the laboratory’s own written procedures, with a documented plan for covering absence.
1. Does the laboratory have a documented minimum staffing level for each operating shift? — Not an informal assumption of “we manage.”
2. Is there a documented plan for covering unplanned absence that doesn’t rely on an already-fatigued remaining staff member working alone? — Relevant especially for small or single-staffed sections.
3. Have critical procedures ever been delayed or skipped due to understaffing, and if so, was this logged as a quality event? — Understaffing-driven shortcuts that go unrecorded are a hidden risk.
Equipment, Reagents & Traceability
Open full guidance for Standard 4 — worked examples, first steps, monitor methods →
Calibration Current on Every Reportable Instrument
Non-Negotiable
Every instrument used to generate a reportable patient result has a current, traceable calibration record, and no instrument is used past its calibration due date without being formally removed from service first.
1. Pick any analyzer in current use — is its calibration record current, with a traceable certificate or reference standard? — Not a certificate from a prior calibration cycle still displayed.
2. Is there any instrument past its calibration due date still generating reportable results? — A single instance of this is a direct patient-safety failure.
3. Where an instrument is taken out of service, is it physically or digitally flagged so staff cannot use it by mistake? — An unflagged out-of-service instrument gets used under time pressure.
Preventive Maintenance on a Fixed Schedule
Non-Negotiable
Every piece of critical equipment is maintained according to the manufacturer’s recommended schedule or a validated equivalent, with maintenance records retained and reviewed before each instrument returns to reportable use after service.
1. Does a maintenance log exist for critical equipment showing the manufacturer’s recommended interval was actually met? — Not a schedule that exists on paper but is routinely missed.
2. After servicing, is there a documented verification step before the instrument returns to reporting patient results? — Returning equipment to use immediately after service, with no verification, is a gap.
3. Are maintenance records retained for the full retention period set in Standard 1.5? — Equipment history is frequently the specific record type that gets discarded early.
Reagent Lot Verification Before Use
Non-Negotiable
Each new reagent lot is verified against the laboratory’s own quality control material before being used for reportable patient results, and expired reagents are physically segregated from, and never used in, active testing.
1. Can the laboratory show lot-verification records for its currently open reagent lots? — A new lot opened and put directly into use without verification is a direct failure.
2. Are expired reagents physically separated from current stock, not just marked and left in the same storage area? — Separation prevents accidental use under time pressure far more reliably than a label alone.
3. Is reagent storage temperature monitored and logged, with a documented response procedure for excursions? — Temperature-sensitive reagents used after an unlogged excursion risk invalid results.
Metrological Traceability to a Recognized Reference
Core
Calibration of measuring equipment is traceable through an unbroken chain to an internationally recognized reference material or method, documented at each link, not simply asserted by the equipment manufacturer.
1. Can the laboratory produce documentation showing the traceability chain for a selected instrument back to a recognized reference? — A manufacturer’s general claim of traceability, with no laboratory-specific documentation, is insufficient.
2. Where a reference material is used, is its own certificate of traceability on file and current? — An expired reference material certificate breaks the chain.
3. Is the traceability chain reviewed whenever equipment or reference materials change? — A chain established once and never revisited can silently break.
Equipment Malfunction: Documented Response
Core
A written procedure governs the laboratory’s response to equipment malfunction, including immediate removal from reportable use, assessment of results produced since the last verified-good check, and notification of affected clinicians where results may be unreliable.
1. Does the malfunction procedure require assessing results produced since the last known-good check, not only results produced after the malfunction was noticed? — A malfunction is often identified after it began, not at its onset.
2. Is there a documented instance of a clinician being notified after a malfunction affected previously reported results? — If this has never happened, ask whether it’s because it’s never been needed, or because the step is skipped.
3. Is the malfunction procedure accessible to staff during an actual event, not only during planned audits? — A procedure staff can’t locate under pressure is not functioning.
Facilities, Environment & Suppliers
Open full guidance for Standard 5 — worked examples, first steps, monitor methods →
Environmental Conditions Monitored and Logged
Non-Negotiable
Temperature, humidity, and other environmental conditions affecting test validity are continuously monitored in each relevant area, logged, with a documented, time-bound response procedure for excursions outside defined limits.
1. Is environmental monitoring actually logged, not just equipped with a sensor nobody checks? — A thermometer on the wall with no log is not monitoring.
2. Where an excursion occurred, is there a documented record of what action was taken and when? — An excursion logged with no follow-up action recorded is incomplete.
3. Are defined limits specific to each area’s actual requirements, not one generic range applied everywhere? — Reagent storage and specimen processing areas often have different real requirements.
Physical Separation of Incompatible Activities
Non-Negotiable
Activities that could cross-contaminate or interfere with each other — specimen reception and clean processing, molecular amplification stages, biohazardous waste handling and clean workspace — are physically separated according to recognized practice for each discipline operated.
1. Is specimen reception physically separated from areas where processed samples are handled? — Shared space for both creates genuine cross-contamination risk.
2. Where molecular testing is performed, are pre- and post-amplification areas separated per recognized practice? — This is a well-established, specific requirement where applicable, not a general suggestion.
3. Is biohazardous waste handling physically separated from clean workspace and specimen processing? — Shared pathways between waste and clean work areas are a recurring, identifiable risk.
Access Control to the Testing Area
Core
Access to the active testing area is restricted to authorized personnel, with visitor and non-laboratory staff access logged and escorted, protecting both specimen integrity and staff safety.
1. Is the testing area physically restricted, not an open space any staff member can enter? — A locked door or controlled entry point, not an honor-system expectation.
2. Is non-laboratory visitor access logged, with a record of who entered and when? — Unlogged access makes any later investigation of a contamination or security concern impossible.
3. Are visitors actually escorted, or left to move through the space unaccompanied? — A stated escort policy that isn’t followed in practice fails this.
Utility Failure: Documented Contingency
Core
A written contingency plan covers loss of power, water, or network connectivity, including protection of in-process specimens and stored reagents, and is tested at a defined interval rather than existing only as an untested document.
1. Does the plan specifically address protection of specimens and reagents already in process at the moment of failure? — Generic continuity language without this detail misses the point most relevant to patient safety.
2. Has the plan been tested within a defined interval, with a record of what the test found? — An untested plan frequently fails in ways nobody anticipated.
3. Do staff on shift know where to find the plan and what their specific role in it is? — A plan known only to management does not function during an actual event at 2am.
Waste Segregated by Hazard Class
Non-Negotiable
Biohazardous, chemical, and sharps waste are segregated at the point of generation into clearly marked, appropriate containers, with documented disposal through a licensed contractor or equivalent regulated pathway.
1. Are the correct waste containers actually present and in use at each bench, not centralized in a way that encourages mixing? — Segregation only works if the right container is within reach at the point of generation.
2. Is there documentation of licensed, regulated disposal, not an informal arrangement? — A disposal manifest or equivalent record, verifiable on request.
3. Are sharps containers replaced before reaching unsafe fill levels, verified by spot check? — An overfilled sharps container is an immediate, specific injury risk.
Critical Supplier Agreements, Documented
Standard
Agreements with critical suppliers — reagent manufacturers, waste contractors, reference laboratories — are documented in writing, specifying the service or product, quality expectations, and renewal terms.
1. Does a written agreement exist for each critical supplier, not an informal, undocumented working relationship? — Especially relevant for long-standing suppliers where formal paperwork is sometimes allowed to lapse.
2. Do agreements specify quality expectations relevant to patient safety, not only commercial terms? — A contract covering price and delivery but silent on quality standards is incomplete for this purpose.
3. Is there a process for renewing or re-evaluating agreements before they lapse? — An expired agreement still being operated under is a gap worth noting even if the relationship itself continues smoothly.
Pre-Examination: Specimen Pathway
Open full guidance for Standard 6 — worked examples, first steps, monitor methods →
Two-Identifier Patient Verification
Non-Negotiable
Before specimen collection, the patient’s identity is verified using at least two independent identifiers — never room number or visual recognition alone — and the verification is actively performed, not merely asked as a rhetorical formality.
1. Observe a live collection — are two genuine identifiers actually checked, not just a name spoken while the patient is expected to confirm passively? — “You’re Mrs. Johnson, right?” to a half-asleep patient is not active verification.
2. Is room number or bed number ever used as one of the two identifiers? — Room numbers change; using one as an identifier is a specific, recurring failure mode.
3. For a patient unable to confirm identity verbally, is there a documented alternative verification procedure? — Unconscious, pediatric, or language-barrier patients need a real, written alternative, not an exception that defaults to no verification.
4. Is the patient’s right to decline specimen collection genuinely honoured, with staff able to describe what happens when a patient exercises it? — A real right, not an assumption that arriving for the test obligates the patient to complete it.
Specimen Labeled at the Point of Collection
Non-Negotiable
Every specimen is labeled in the presence of the patient, immediately following collection, before moving to the next patient or task — never batch-labeled afterward from memory or a separate list.
1. Is labeling observed to happen at bedside/chairside, before the collector moves on? — Pre-printed labels applied later, away from the patient, is a well-documented cause of mix-ups.
2. Are there any workflows where multiple specimens are collected before any labeling occurs? — Even a short delay across several patients creates real mix-up risk.
3. Does the label include enough information to re-verify identity independently of the collector’s memory? — At minimum, two identifiers plus date/time of collection.
Rejection Criteria, Applied Consistently
Non-Negotiable
Written specimen rejection criteria — hemolysis, clotting, insufficient volume, unlabeled or mislabeled specimens, wrong container — are applied consistently regardless of how difficult the specimen was to obtain or who is requesting results urgently.
1. Can staff describe the rejection criteria without looking them up? — If criteria exist only on paper and staff don’t actually know them, they aren’t functioning.
2. Is there a documented instance of a specimen being rejected despite clinical pressure to proceed anyway? — Evidence the criteria hold even under pressure, not just when convenient.
3. Is rejection logged with reason and communicated back to the requesting clinician, not just silently discarded? — Silent rejection can delay care without anyone realizing why results never arrived.
Transport Conditions Preserve Specimen Integrity
Non-Negotiable
Specimens requiring specific transport conditions — temperature, time limits, light protection — are transported accordingly, with the conditions actually monitored, not assumed to be met because a general policy exists.
1. For temperature-sensitive specimens, is the actual transport temperature verified, not just assumed from the container type used? — An insulated bag without verification is an assumption, not a control.
2. Is time from collection to receipt tracked for time-sensitive analytes? — Without a timestamp at both ends, a transport delay goes undetected.
3. Where a specimen arrives outside acceptable transport conditions, is this documented and does it affect result interpretation or trigger rejection? — A condition breach that’s noted but has no consequence for the result is not a real control.
Chain of Custody for Forensic or Legal Specimens
Core
Where the laboratory processes specimens with forensic, legal, or chain-of-custody requirements, a documented, unbroken custody record accompanies the specimen from collection through final disposition, with every handler’s signature and timestamp.
1. Does a chain-of-custody form exist, with every transfer point requiring a signature, not just collection and final testing? — A gap anywhere in the chain undermines the specimen’s legal validity.
2. Are chain-of-custody specimens physically secured differently from routine specimens? — Locked storage or restricted access, not sitting in the same open rack as routine work.
3. Is staff specifically trained on chain-of-custody requirements, distinct from routine specimen handling training? — Routine training alone does not cover the additional legal requirements.
Specimen Accessioning Logged in Real Time
Core
Specimen receipt is logged in the laboratory information system at the time of actual receipt, creating a verifiable, time-stamped record of when the specimen entered the laboratory’s custody, not backdated to match the collection time.
1. Does the accessioning timestamp reflect actual receipt time, verifiable against another independent record such as a courier log? — A timestamp that always exactly matches the requested collection time, with no variation, suggests backdating rather than real-time logging.
2. Is there a backlog where specimens sit unaccessioned for a meaningful period before entry? — A delay here distorts turnaround-time reporting and can delay result release.
3. Can the laboratory produce the accessioning record for any specimen the Monitor selects, on request? — Immediately retrievable, not reconstructed after the fact.
Urgent/STAT Specimens Prioritized and Tracked
Core
A written procedure defines how urgent or STAT specimens are flagged, prioritized through processing, and tracked against a defined turnaround-time target, distinct from routine specimen handling.
1. Is there a visible, physical or digital flagging system that actually changes how a STAT specimen is handled, not just a label with no operational effect? — A “STAT” sticker that doesn’t change queue position accomplishes nothing.
2. Is STAT turnaround time actually tracked and reviewed, with a defined target? — Without tracking, there’s no way to know whether the prioritization is actually working.
3. Where STAT turnaround targets are missed, is this logged and reviewed as a quality event? — Missed STAT targets with no follow-up suggest the system tolerates the failure.
Specimen Retention Before Discard
Standard
Tested specimens are retained for a defined minimum period appropriate to the test type before discard, allowing repeat testing or additional analysis to be requested without recollection.
1. Does a written retention schedule exist by specimen and test type, not one blanket period applied regardless of test? — Different analytes have genuinely different stability and retention needs.
2. Is retained specimen storage condition-appropriate, matching what the specimen actually requires? — Retained specimens stored incorrectly are effectively unusable if a repeat test is later needed.
3. Can the laboratory locate and retrieve a specific retained specimen within its stated retention window? — A retention policy that exists but fails in practice when a specimen is actually needed again.